6234 Sunscreen Sun Essential

6234 Sunscreen Sun Essential
SPL v3
SPL
SPL Set ID 19d4a38f-b071-410a-87e5-f1cb51ae7d37
Route
TOPICAL
Published
Effective Date 2012-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (17.75 g) Titanium Dioxide (14.2 g)
Inactive Ingredients
Alanine Aloe Vera Leaf Arginine Ascorbic Acid Ascorbyl Palmitate .alpha.-bisabolol, (+/-)- Caprylic/capric Mono/diglycerides Cetearyl Isononanoate Cetyl Alcohol Citric Acid Monohydrate Coconut Ethylhexylglycerin Glycerin Glyceryl Monostearate Glycine Sunflower Oil Mica Niacin Olea Europaea Leaf Panthenol Phenoxyethanol Lecithin, Soybean Potassium Sorbate Sodium Pyrophosphate Pentylene Glycol Propanediol Almond Oil Rosa Moschata Oil Rosemary Hyaluronate Sodium Sodium Citrate Sorbitan Tocopherol Urea Grape Seed Oil Xanthan Gum Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-06-01

Description

For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center right away.


Medication Information

Warnings and Precautions

For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center right away.

Dosage and Administration

Helps prevent sunburn. If used as directed with other sun protection measured decreases the risk of skin cancer and early skin aging caused by the sun. Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply: at least 2 hours. Children under 6 months: Ask a doctor. Sun protection measurements. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m - 2 p.m. Wear long-sleeve shirts, pants, hats, and sunglasses. Protect this product from excessive heat and direct sun

Description

For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center right away.

Section 50565-1

For external use only.

Avoid contact with eyes.

Keep out of reach of children.

Do not apply to open wounds.

STOP USE AND ask a doctor if condition worsens or

symptoms persist for more than seven days, discontinue

use of the product.

Section 51727-6

ALANINE, ALOE VERA LEAF, ARGININE, ASCORBIC ACID, ASCORBYL PALMITATE, .ALPHA.-BISABOLOL, (+/-)-,CAPRYLIC/CAPRIC MONO/DIGLYCERIDES, CETEARYL ISONONANOATE, CETYL ALCOHOL, CITRIC ACID MONOHYDRATE, COCONUT, ETHYLHEXYLGLYCERIN, GLYCERIN, GLYCERYL MONOSTEARATE, GLYCINE, SUNFLOWER OIL, MICA, NIACIN, OLEA EUROPAEA LEAF, PANTHENOL, PHENOXYETHANOL, LECITHIN, SOYBEAN, POTASSIUM SORBATE, SODIUM PYROPHOSPHATE, PENTYLENE GLYCOL, PROPANEDIOL, ALMOND OIL, ROSA MOSCHATA OIL, ROSEMARY, HYALURONATE SODIUM, SODIUM CITRATE, SORBITAN, TOCOPHEROL, UREA, GRAPE SEED OIL, XANTHAN GUM, WATER

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Titanium Dioxide, Octinoxate


Structured Label Content

Dosage and Administration (34068-7)

Helps prevent sunburn. If used as directed with other sun protection measured decreases the risk of skin cancer and early skin aging caused by the sun. Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply: at least 2 hours. Children under 6 months: Ask a doctor. Sun protection measurements. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m - 2 p.m. Wear long-sleeve shirts, pants, hats, and sunglasses. Protect this product from excessive heat and direct sun

Warnings and Precautions (34071-1)

For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center right away.

Section 50565-1 (50565-1)

For external use only.

Avoid contact with eyes.

Keep out of reach of children.

Do not apply to open wounds.

STOP USE AND ask a doctor if condition worsens or

symptoms persist for more than seven days, discontinue

use of the product.

Section 51727-6 (51727-6)

ALANINE, ALOE VERA LEAF, ARGININE, ASCORBIC ACID, ASCORBYL PALMITATE, .ALPHA.-BISABOLOL, (+/-)-,CAPRYLIC/CAPRIC MONO/DIGLYCERIDES, CETEARYL ISONONANOATE, CETYL ALCOHOL, CITRIC ACID MONOHYDRATE, COCONUT, ETHYLHEXYLGLYCERIN, GLYCERIN, GLYCERYL MONOSTEARATE, GLYCINE, SUNFLOWER OIL, MICA, NIACIN, OLEA EUROPAEA LEAF, PANTHENOL, PHENOXYETHANOL, LECITHIN, SOYBEAN, POTASSIUM SORBATE, SODIUM PYROPHOSPHATE, PENTYLENE GLYCOL, PROPANEDIOL, ALMOND OIL, ROSA MOSCHATA OIL, ROSEMARY, HYALURONATE SODIUM, SODIUM CITRATE, SORBITAN, TOCOPHEROL, UREA, GRAPE SEED OIL, XANTHAN GUM, WATER

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Titanium Dioxide, Octinoxate


Advanced Ingredient Data


Raw Label Data

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